Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

Par Pharmaceuticals

Endo International plc issued a press release announcing that one of its pharmaceutical companies, Par Pharmaceuticals, is issuing a voluntary recall of a single lot of one of its medications.¹ The lot, which is being recalled on the consumer, may potentially be tainted with silicon particulates in the product solution.

The recalls order is for one lot of Treprostinil Injection 20mg/20ml (1mg/mL). This specific lot was reportedly distributed to wholesalers between June 16, 2022 and October 17, 2022. According to the company, it has yet to receive any reports of injuries due to the contamination, and the recall appears to be a preemptive move. Endo warns that particulates entering the body through an injected solution may cause of a variety of problems.

The particulates may simply cause local irritation or swelling at the site of the injection. However, if the particulates enter the bloodstream, they can potentially cause a variety of serious issues, including stroke or death.

Treprostinil Injection is a treatment for pulmonary arterial hypertension (PAH). This is a form of pulmonary hypertension, which causes high blood pressure in the lungs. PAH occurs due to some sort of obstruction in the small arteries in the lungs.² This can cause shortness of breath, fatigue, edema, dizziness, chest pain, heart palpitations, blue lips or fingers, cough, and hoarseness in the voice.

There is no cure for PAH, but there are multiple medications on the market that can reduce the symptoms and improve the patient’s quality of life. According to Par, Treprostinil is used to treat symptoms brought about after exercising.

As part of the recall, Par is contacting both wholesalers and hospitals it believes may have received medications from the impacted lot. It is urging that any wholesalers or hospitals that have medications from the lot should immediately stop any use or distribution. Any patients who have potentially used medication from this lot should report any possible adverse symptoms to their doctor or HCP immediately.

Any adverse reactions should also be reported to the FDA’s MedWatch Adverse Event Reporting program. FDA has been notified of the recall.

Source

1. Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution. Endo. March 12, 2024. Accessed March 13, 2024. https://investor.endo.com/news-releases/news-release-details/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot
2. Pulmonary Arterial Hypertension (PAH). American Lung Association. Accessed March 13, 2024. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-arterial-hypertension